A Study to Evaluate the Efficacy and Safety of Seroquel in Chinese Han Patients With Schizophrenia

Summary

The primary objective of this study is to evaluate the efficacy of seroquel in the treatment
of patients with acute schizophrenia compared with risperidone by evaluating the change of
PANSS total score from the baseline to week 6.

Description

This is a rater- blind, parallel assignment, randomized and active controlled study. The
subjects investigated are outpatients or inpatient with schizophrenia from the Chinese Han
race. The screening phase lasts for 1 week. The eligible patients enter the next randomized
treatment phase. The titration duration is 1 week. After the first week, the patients are
administered with a flexible dose regimen. In this study, the effective doses range of
seroquel and risperidone are 600-750mg/d and 3-6mg/d respectively and the treatment duration
lasts for 6 weeks.

The efficacy and safety of seroquel in the treatment of patients with schizophrenia have
been confirmed by multiple double blind studies. This study is designed to evaluate the
efficacy and safety of seroquel in the treatment of Chinese Han patients with schizophrenia.
Therefore, the single blind and active control design should be selected for this study. The
drug titration method and dose are within the range specified in the instruction and
patients with schizophrenia are tolerant to the drug in clinical treatment.

The purpose of schizophrenic patient treatment is to improve the core symptoms, prevent
suicide and other aggressive behavior, alleviate the side reactions caused by the drug, and
recover the life functions of patients. Generally, the treatment in the acute phase lasts
for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 6 weeks.

The rating scales used in this study are standard psychiatric rating scales with good
validity and are widely used in the study of antischizophrenia drugs and in the treatment of
patients with schizophrenia in China. The PANSS is developed from two early rating scales,
namely the brief psychiatric rating scale (BPRS) and the psychiatric rating scale. The high
inter-investigator reliability and repeated measurement reliability of these scales have
been proved by multiple studies. The clinical global impression (CGI) is a simple but
convenient global impression scale. It is applicable to any patients treated and studied by
the psychiatric department. The Carlgary depression scale for schizophrenia (CDSS) is used
to evaluate the depressive symptoms of patients with schizophrenia. It has good reliability
and validity. The abnormal involuntary movement scale (AIMS) is another evaluation tool
consisting of 12 items. The AIMS is used to evaluate the abnormal involuntary movements
related to antischizophrenia drugs. The AIMS is nearly the most frequently used multi-item
rating scale evaluating of tardive dyskinesia. The Simpson and Angus scale (SAS) is also a
rating scale commonly used since its release in 1970. The validity of SAS has been verified
in the double blind and placebo-controlled study involving two haloperidol doses.

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Medical and Biotech [MESH] Definitions

Risperidone

A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.

Paliperidone Palmitate

A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.

Quetiapine Fumarate

A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.

Schizophrenia, Paranoid

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

Schizophrenia, Catatonic

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

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